difficulties recruiting participants
Evaluation Der Intraoperativen Umsetzung Von 3D Geplanten Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen Durch Eine Quantitative Postoperative Erfolgskontrolle
Sponsor study identifier
interventional
7
1 country
2
Study Start
July 30, 2017
Actual (reported)Primary Completion
May 10, 2019
Actual (reported)Study Completion
May 10, 2019
Actual (reported)Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 10, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2016
Actual (reported)July 11, 2016
Actual (reported)July 30, 2017
Actual (reported)May 10, 2019
Actual (reported)May 10, 2019
Actual (reported)3D difference between preoperative plan and surgery
For each surgery the discrepancy of the postoperative result compared to the preoperative planning is calculated by measuring all 6 degrees of freedom (3xrotation, 3xtranslation). The discrepancy between a simulated perfect postoperative result and the actual postoperative result is assessed in degree (rotation) and millimeters (translation). These measures are used to compare the outcome of the two different study Groups.
12 months
surgical outcome assesed by validated outcome instruments
12 months
range of motion
12 months
fracture fixation with 3D planning and use of patient-specific instruments
standard procedure of fracture Fixation without 3D planning and without use of patient-specific instruments
Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation
Universital Hospital Zurich
Zurich, 8001, Switzerland
University Hospital Balgrist
Zurich, 8008, Switzerland
Phillipp Furnstahl, PhD
Balgrist University Hospital
Philipp Furnstahl, PhD
Balgrist University Hospital
7 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2016
First Posted
July 11, 2016
Study Start
July 30, 2017
Actual (reported)the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
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Primary Completion
May 10, 2019
Actual (reported)Study Completion
May 10, 2019
Actual (reported)Last Updated
July 12, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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